Enquires, questions?

FAQs

We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

1. How do I know if you can work with my device?

   We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

2. Are you a CRO (Contact Research Organisation)?

   No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

3. Will my enquiry be dealt with confidentially?

   Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

4. How can I be assured of a quality service?

   Our medical device regulatory consulting is built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

5. What if I don't know much about the MDR?

   We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

6. Do you work with medical software?

   Yes. Software as a Medical Device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on Software as a Medical Device.

7. What is the advantage of working with medical professionals?

   At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

8. What is your pricing strategy?

   We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

9. We need a large amount of work doing. Can you scale to meet our requirements?

   Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

10. Do you offer MDR training?

    Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.